UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025108
Receipt number R000028863
Scientific Title Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG)
Date of disclosure of the study information 2016/12/01
Last modified on 2022/06/06 16:43:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG)

Acronym

KOTOSG-CFZ observational study

Scientific Title

Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG)

Scientific Title:Acronym

KOTOSG-CFZ observational study

Region

Japan


Condition

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to reveal the efficacy and the safety of Carfilzomib in the real-world practice in Japan by the Kyoto Clinical Hematology Study Group (KOTOSG) multi-instituitional observational analyses of patients' background, the content of Carfilzomib-included therapy, therapeutic outcome and efficacy, and safety including adverse events.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy of Carfilzomib-containing therapy for multiple myeloma

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

99 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients between 20 and 99 years old who received Carfilzomib-containing therapy

Key exclusion criteria

Patients who reject the enrollment in the study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name JUNYA
Middle name
Last name KURODA

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Hamatology and Oncology

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5740

Email

junkuro@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name JUNYA
Middle name
Last name KURODA

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Hamatology and Oncology

Zip code

6028566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5740

Homepage URL


Email

junkuro@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ono Pharmaceutical Co.Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine Ethical Review Board form Medical research

Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

京都府立医科大学附属病院、京都第一赤十字病院、京都第二赤十字病院、京都鞍馬口医療センター、愛生会山科病院、福知山市民病院(いずれも京都府)、松下記念病院(大阪府)、近江八幡総合医療センター、大津市民病院(滋賀県)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

50

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 02 Month 05 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 09 Day

Date of IRB

2017 Year 05 Month 09 Day

Anticipated trial start date

2017 Year 06 Month 26 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 06 Month 06 Day

Date trial data considered complete

2022 Year 06 Month 06 Day

Date analysis concluded

2022 Year 06 Month 06 Day


Other

Other related information

Observation items in this study are listed as follows.

1 Bone marrow analysis
all nucleated cell count, myeloma cell ratio
2 Blood examination
complete blood cell count, LDH, AST, ALT, ALP, BUN, Cre, Na, K, Ca, IP, UA, CRP, beta-2-microglobulin, BNP(or NT-proBNP),immunoglobulin, serum free light chain, KL-6, PT, APTT, Fibrinogen, FDP, etc.
3 Urinary test
4 Radiologic examinations
Chest X-ray, Abdominal X-ray, CT, Cardiac ultrasonography, etc.
5 Physical examination
6 Adverse events evaluated by CTCAE v.4.0.


Management information

Registered date

2016 Year 12 Month 01 Day

Last modified on

2022 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028863


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name